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Cancer decentralized clinical trials in the Veterans Health Administration
Daphne R Friedman1,2,3, Shannon L Elam2, Sarah Bloemers4
1National Oncology Program, US Department of Veterans Affairs, Washington, DC, United States.
Decentralized clinical trials in cancer care can overcome enrollment barriers. Sharing Veterans Health Administration (VA) experiences can help implement these innovative cancer trials more widely.
Area of Science:
- Oncology
- Clinical Trial Design
- Healthcare Innovation
Background:
- Enrollment barriers hinder cancer clinical trial progress.
- Decentralized clinical trials (DCTs) offer solutions by conducting research remotely, addressing patient and site-specific challenges.
Purpose of the Study:
- To describe the implementation and outcomes of a cancer-focused decentralized clinical trial program within the Veterans Health Administration (VA).
Main Methods:
- The VA established a dedicated cancer DCT program with standardized protocols.
- Collaboration with VA research offices and institutional review boards ensured compliance.
- Ten trials (2 observational, 5 nontherapeutic, 3 therapeutic) were implemented, with 8 fully remote and 2 hybrid models.
Main Results:
- 134 Veterans enrolled across 47 VA medical centers.
- Participant demographics reflected the broader VA cancer patient population, including rural (31%) and minority (19%) individuals.
- Methods for remote research conduct were successfully employed.
Conclusions:
- Cancer DCTs can effectively mitigate enrollment barriers.
- Not all trials are suitable for decentralization.
- Sharing VA's DCT experiences facilitates broader adoption by sponsors and researchers.
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